MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSLYRIC¿; FLOW CYTOMETRIC REAGENTS AND ACCESS

Catalog Number	662875
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.G.5.Pma / 510(k)#: k170974.G.5.Pma / 510(k)#: k201814.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd facslyric¿ flow cytometer, the customer encountered carryover involving patient samples.There was no report of user impact.The following information was provided by the initial reporter."blood on the tube is expose to di water.Happening for a while.Fse already visit several times.¿ contamination: 1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown - go to question #2.Carryover between patient samples.2.Please describe any additional details: go to patient samples checklist.Blood on the tube is expose to di water.Contamination: 1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown - go to question #2.No.2.Please describe any additional details: go to patient samples checklist.Patient samples checklist: 1.Did this cause erroneous results on patient samples for diagnostic testing? if yes, go to question #2.If no, no further questions required.No.
Additional Manufacturer Narrative
H.6 investigation summary: based on the investigation results, the reported issue of carryover was confirmed.The potential cause was determined to be a contaminated sit arm assembly and sample line tubing.The fse investigated the issue and replaced these components, which resolved the issue and returned the instrument to operational status.This issue did not impact patient diagnosis or treatment and no user or patient was harmed or injured.The complaint sample was not requested to be returned because the complaint was confirmed through other elements of the investigation.Review of the dhr confirmed that the instrument met all the manufacturing specifications prior to release.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that while using bd facslyric¿ flow cytometer, the customer encountered carryover involving patient samples.There was no report of user impact.The following information was provided by the initial reporter."blood on the tube is expose to di water.Happening for a while.Fse already visit several times.¿ contamination: 1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown - go to question #2.Carryover between patient samples.2.Please describe any additional details: go to patient samples checklist.Blood on the tube is expose to di water.Contamination: 1.Were patient samples contaminated or was there carryover (cross-contamination/mixing) between patient samples? if no, no further questions required.Patient samples contaminated, carryover between patient samples, unknown - go to question #2.No.2.Please describe any additional details: go to patient samples checklist.Patient samples checklist: 1.Did this cause erroneous results on patient samples for diagnostic testing? if yes, go to question #2.If no, no further questions required.No.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer Contact: fahmy razak - mdr ; 155 north mccarthy boulevard; milpitas, CA 95035 ; 8772328995
• MDR Report Key: 21912729
• Report Number: 3027394506-2025-00020
• Device Sequence Number: 9125537
• Product Code: OYE
• UDI-Device Identifier: 00382906628756
• UDI-Public: (01)00382906628756(11)220127
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK230835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 662875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown